+Artikel 82 AI-systemer, som overholder kravene, men som udgør en risiko
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Artikel 82 AI-systemer, som overholder kravene, men som udgør en risiko

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1. Oversigt

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Artikel 82 1.
Hvis en medlemsstats markedsovervågningsmyndighed efter at have foretaget en vurdering i henhold til artikel 79 og efter høring af den relevante nationale offentlige myndighed, der er omhandlet i artikel 77, stk. 1, finder, at et højrisiko-AI-system, selv om det overholder kravene i denne forordning, alligevel udgør en risiko for personers sundhed eller sikkerhed, for grundlæggende rettigheder eller for andre aspekter vedrørende beskyttelse af samfundsinteresser, skal den pålægge den relevante operatør uden unødigt ophold at træffe alle nødvendige foranstaltninger for at sikre, at det pågældende AI-system, når det bringes i omsætning eller ibrugtages, ikke længere udgør en sådan risiko, inden for en tidsfrist, som den kan fastsætte.
Artikel 82 2.
Udbyderen eller en anden relevant operatør sikrer, at der foretages korrigerende tiltag med hensyn til alle de pågældende AI-systemer, som vedkommende har gjort tilgængelige på EU-markedet, inden for den tidsfrist, der er fastsat af medlemsstatens markedsovervågningsmyndighed, der er omhandlet stk. 1.
Artikel 82 3.
Medlemsstaterne underretter omgående Kommissionen og de øvrige medlemsstater om resultaterne i henhold til stk. 1. Denne underretning skal indeholde alle tilgængelige oplysninger, især de nødvendige data til identifikation af de pågældende AI-systemer, AI-systemets oprindelse og forsyningskæde, arten af den pågældende risiko og arten og varigheden af de trufne nationale foranstaltninger.
Artikel 82 4.
Kommissionen hører uden unødigt ophold de berørte medlemsstater og de relevante operatører og vurderer de trufne nationale foranstaltninger. På grundlag af resultaterne af denne vurdering træffer Kommissionen afgørelse om, hvorvidt foranstaltningen er berettiget, og foreslår om nødvendigt andre passende foranstaltninger.
Artikel 82 5.
Kommissionen meddeler omgående sin afgørelse til de pågældende medlemsstater og til de relevante operatører. Den underretter også de øvrige medlemsstater.

1.1 Referencer

1.2 Identificerede krav

1.3 Relaterede standarder

2. Identificerede krav

Krav

3. Relaterede standarder

Standarder
SCF Non-Conformity Corrective Action

Description

Mechanisms exist to implement corrective action to remediate instances of non-conformity with applicable statutory, regulatory, and/or contractual compliance obligations.

Possible Solutions & Considerations

Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2

∙ Corrective action log (spreadsheet)
∙ Documented remediation plans for audit findings

Small Business (10-49 staff) / BLS Firm Size Classes 3-4

∙ Corrective action register with remediation tracking
∙ Management review of open findings

Medium Business (50-249 staff) / BLS Firm Size Classes 5-6

∙ Formal corrective action plan process
∙ GRC platform for finding tracking and remediation
∙ Management review of open findings

Large Business (250-999 staff) / BLS Firm Size Classes 7-8

∙ Enterprise corrective action management program
∙ GRC platform with workflow-driven remediation tracking
∙ Executive reporting on open findings

Enterprise (> 1,000 staff) / BLS Firm Size Class 9

∙ Enterprise GRC platform for corrective action management
∙ Automated finding tracking and escalation workflows
∙ Board-level reporting on material findings

SCR-CMM

Level 0 Not Performed

Practices are non-existent, based on the inability to demonstrate an implemented and operational capability. A reasonable person would conclude the control is not being performed.

Level 1 Performed Informally

Compliance (CPL) domain capabilities are ad hoc and inconsistent. Capability criteria associated with this control may include:
▪ Policies, standards & procedures associated with CPL domain capabilities provide limited coverage due to the depth and breadth of the existing documentation.
▪ Compliance management-related activities are decentralized (e.g., a localized/regionalized function) and uses non-standardized methods to implement secure, resilient and compliant practices.
▪ Compliance efforts are narrowly-limited to certain compliance requirements.
▪ IT and/or cybersecurity personnel use an informal process to govern statutory, regulatory and contractual compliance obligations.

Level 2 Planned Tracked

Compliance (CPL) capabilities are requirements-driven, but are not standardized across the entity (e.g., local/regional level consistency). Capability criteria associated with this control reasonably expect the following criteria to exist:
▪ Policies and standards associated with CPL domain capabilities are formally documented and centrally-managed by the entity.
▪ Standardized Operating Procedures (SOP) associated with CPL domain capabilities are documented and maintained by process owners.
▪ IT and/or cybersecurity personnel work with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with CPL domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD).
▪ Compliance management controls-related controls are primarily administrative and preventative in nature (e.g., policies, standards and procedures & guidelines).
▪ Compliance management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel.
▪ External compliance requirements for cybersecurity and data privacy are identified and documented, based on applicable laws, regulations and contractual obligations.

Level 3 Well Defined

Compliance (CPL) capabilities are standardized across the entity for applicability to People, Processes, Technologies, Data and/or Facilities (PPTDF) to ensure consistency for Technology Assets, Applications, Services and/or Data (TAASD). Capability criteria associated with this control reasonably expect the following criteria to exist:
▪ Policies and standards associated with CPL domain capabilities are formally documented and centrally-managed by the entity's Governance, Risk & Compliance (GRC) team, or similar function.
▪ Standardized Operating Procedures (SOP) associated with CPL domain capabilities are well-documented and kept current by process owners.
▪ A Governance, Risk & Compliance (GRC) team, or similar function, is appropriately staffed and supported to implement and maintain CPL domain capabilities.
▪ Technology is leveraged to enhance the efficiency and accuracy of governance, risk management and compliance operations (e.g., GRC platform).
▪ The entity's Governance, Risk & Compliance (GRC) team, or similar function, works with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with CPL domain capabilities to address Minimum Compliance Requirements (MCR) (e.g., applicable statutory, regulatory and/or contractual requirements) and Discretionary Security Requirements (DSR) (e.g., entity-required controls).
▪ An implemented and operational capability exists to take corrective action to remediate instances of non-conformity with applicable statutory, regulatory, and/or contractual compliance obligations.

Level 4 Quantitatively Controlled

Utilize SCR-CMM Level 3 criteria definitions:
▪ There are no defined Level 4 criteria, since it is reasonable to assume a quantitatively-controlled process is not necessary to operationalize this control.
▪ While it may be possible to develop “metrics-driven” capabilities for this control, the criteria would be organization-specific to define.

Level 5 Continuously Improving

Utilize SCR-CMM Level 3 or Level 4 (if available) criteria definitions:
▪ There are no defined Level 5 criteria, since it is reasonable to assume a continuously-improving process is not necessary to operationalize this control.
▪ Level 5 capabilities should be considered “world-class” where the control builds on Level 4 capabilities, but are continuously improving through Artificial Intelligence (AI) and/or Machine Learning (ML) technologies.
▪ While it may be possible to develop responsive capabilities for this control through the use of AI and/or ML technologies, the criteria would be organization-specific to define.